The repair of separated or dislocated bone fragments or segments following bone surgery or injury requires realignment of the separated, broken, or dislocated fragments or segments and subsequent secure fixation for promoting proper natural rejoinder, of these bone fragments or segments, e.g. by osteosynthesis.
It is therefore desirable to accomplish as completely as possible an immobilization of the fracture or osteotomy site. This involves the stabilization of affected bone segments relative to each other and in relation to the surrounding bone structure. The aim of fixation of adjacent bone portions is to immobilize the fracture or osteotomy site in order to promote localized bone growth in the natural repair of the separation.
One example of an area in which such procedures are desirable is in the refixation of large area bone segments of the skull cap in neurosurgical and craniofacial operations on or through the vault of the human skull.
Another example is in the surgical treatment of craniofacial abnormalities, wherein one or more bone segments of the skull cap may be removed and reappointed to achieve a desired cosmetic result before refixation in a displaced position relative to the surrounding bone. These operations serve to correct malformations of the skull cap which are present at birth, such operations are often performed during the infancy of the patient.
At the end of such procedures, the previously removed bone fragment or fragments are repositioned into their original locations, or in different desired locations.
Known methods for providing fixation between adjacent bone portions have included the use of metallic plates of varying configurations (osteosynthesis plates), which are secured across osteotomies or fracture sites by metallic bone screws inserted with a screwdriver.
The typical prior-art apparatus and device used for the fixation of osteosynthesis plates is a screwdriver and self-tapping screw. Because the implementation of this apparatus and device is user dependent, users may easily strip out bone tissue causing the screw to no longer secure the plate to the bone or misalign the screw head with respect to the pre-drilled hole in the plate, creating a sharp edge and possible dermis irritation. The loading of the screw onto the screwdriver and the tightening process is time consuming. Screws are loaded by hand, one at a time, and are often lost and must be found before skin closure. Two drivers are typically utilized alternately to reduce screw loading delay time.
A need therefore exists for an alternative fastening device for plate/bone fixation, such as a self-centering apparatus pre-loaded with fasteners that do not strip out bone tissue or require the drilling of pilot holes. This device would save considerable time by eliminating screw loading/driving; it would also eliminate re-sterilization concerns and improve surgical outcomes.